A randomized comparative clinical trial to evaluate the efficacy of Simhyadi Choorna Vati and Montelukast + Levocetrizine combination in the management of Peenas Vyadhi( Chronic Rhinitis)in school-going children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Brief CTRI Summary (Lay + Scientific, concise):
Peenas (Chronic Rhinitis) is a common pediatric respiratory disorder caused by repeated exposure to environmental allergens, pollution, and climatic variations. In Ayurveda, Peenas is described as a Vata-Kapha predominant disorder characterized by chronic nasal obstruction, discharge, sneezing, and impaired nasal function, closely resembling features of chronic/allergic rhinitis described in modern medicine. The prevalence of chronic rhinitis in children is rising and significantly affects school attendance and quality of life.
Conventional management with antihistamines, leukotriene antagonists, and nasal steroids often provides only symptomatic relief and may be associated with adverse effects on long-term use. Ayurveda offers time-tested formulations with potential disease-modifying action and better safety profiles.
Simhyadi Choorna Vati, mentioned in Yogratnakar, is traditionally indicated in Peenas due to its Vata-Kapha shamaka properties. Montelukast + Levocetirizine is a commonly used standard modern therapy for chronic/allergic rhinitis. This randomized comparative clinical trial aims to evaluate and compare the efficacy and safety of Simhyadi Choorna Vati versus Montelukast + Levocetirizine in the management of Peenas (Chronic Rhinitis) in school-going children, thereby generating evidence for integrative and rational pediatric respiratory care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children diagnosed with case of Peenas (Chronic Rhinitis) having Nasavrodha(Nasal Congestion) with two or more presenting symptoms like Nasastrava(Rhinorrhea), Kshavathu(Sneezing),Nasakandu (Nasal Itching),Shirashoola(Headache) for atleast 4 weeks.(AAP guidelines)
- •Children between the ages of 6 to 12 years, irrespective of gender, socioeconomic status.
排除标准
- •Known case of Acute Sinusitis with fever more than 100oF..
- •Nasal polyps or any other clinically significant nasal anomaly.
- •Patient having rhinitis but associated with known case of Asthma.
- •Patient who have received surgical procedure in the nasal cavity within 3 months prior to visit.
- •Those who have started immunosuppressive therapy like inhaled corticosteroids.
研究者
Dr Rutuja Sanjay Abak
PDEAs College of Ayurved and Research Centre ,nigdi ,Pune